There is work ongoing within MedTech Europe on labelling of medical devices.
To support in this work, MedTech Europe have requested the following information from industry by 28 April.
- Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of labelling cost compared to the overall cost of the product). Also, information on how long it takes to implement the label change, even a minor one
- Examples of ‘crowded labels’ and localized labels made for the same device
- Considerations around the use of a symbol for digital labelling (if a symbol would be helpful for identifying the QR code meant to be used as a digital label + any other considerations)
Please provide this information to Ashleigh by 27 April to allow it to be passed to MedTech Europe.
BIVDA are intending to develop a policy paper on labelling within GB which may also utilise some of these points, being managed under the UKCA sub-group. If you would be interested in joining they UKCA group, please let Ashleigh know.